Determining the effect of drug combination (hydrocortisone + ascorbic acid + neurobion) on the prognosis of multiple trauma patients.
Design
In this triple blind randomized controlled clinical trial phase 3, 70 multiple trauma patients were distributed in two groups of 35 intervention and control using random allocation software. In the intervention group, the drug combination of vitamin C + hydrocortisone + neurobion is prescribed and the control group receives a placebo.
Settings and conduct
This triple blind clinical trial study is performed in 1400 in Ayatollah Kashani Hospital in Isfahan. In this study, patients, researchers and evaluators of the outcome of treatment are unaware about the type of drug received by patients,
Participants/Inclusion and exclusion criteria
In this study, multiple trauma patients over the age of 18 with an injury severity greater than 15 are included in the study. Pregnant patients, history of adrenal insufficiency, history of weakened immune system, corticosteroid therapy within the last 6 months, G6PD patients, history of oxalate nephropathy, oliguria or anuria, and patients with a history of allergy or anaphylaxis to any of the drugs hydrocortisone or ascorbic acid or ascorbic acid Are not studied.
Intervention groups
Intervention group: In this group, 1.5 grams of vitamin C is injected every 6 hours for 4 days and 50 mg of hydrocortisone every 6 hours for 6 days and one neurobion ampoule is injected every 4 hours for 4 days.
Control group: In the group, normal saline is injected as a placebo.
Main outcome variables
Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201116049410N1
Registration date:2021-07-14, 1400/04/23
Registration timing:prospective
Last update:2021-07-14, 1400/04/23
Update count:0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
SeyedTaghi Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 0066
Email address
st_hashemi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2022-03-18, 1400/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of treatment with (Hydrocortisone+ Ascorbic acid+ Neurobion) on the prognosis of multiple trauma patients in comparison with control group
Public title
Effect of treatment with (Hydrocortisone+ Ascorbic acid+ Neurobion)on multiple trauma patients
Pregnancy
History of adrenal insufficiency
Patients with history of Immunosuppression
Corticosteroid therapy within the last six months
G6PD patients
Hhistory of oxalate nephropathy
Oliguria or anuria
Known allergy to vitamin C, hydrocortisone, neurobion
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization method. To do this, 70 prepared cards are written on 35 letters of letter A and on 35 other Tides of letter B and the cards are thrown into the box and shuffled well. When each patient enters the intensive care unit, one of the nurses who is not awar about the study, is asked to bring out a card. According to what is written on the card, patients are placed in the intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a three-blind study and patients, researchers and outcome evaluators are unaware of the type of combination received. The drug combination of the two groups in similar packages is prepared by one of the personnel of the intensive care unit who is not under study and is provided to the executor of the project for use.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
َAyatollah Kashani street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.MUI.MEd.REc.1399.518
Health conditions studied
1
Description of health condition studied
multiple trauma
ICD-10 code
T07
ICD-10 code description
Unspecified multiple injuries
Primary outcomes
1
Description
General condition of the patient
Timepoint
Every day
Method of measurement
SOFA score
2
Description
Duration of hospitalization in the intensive care unit
Timepoint
At the time of leaving the Border Special Cases section
Method of measurement
The time interval between entering and leaving the intensive care unit
3
Description
Ventilation time
Timepoint
One time, at the extubation time
Method of measurement
Calculate the number of days connected to the ventilator
4
Description
Prognosis of the disease
Timepoint
Time to leave the intensive care unit
Method of measurement
Determining the patient's recovery status or death
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive 1.5 g of vitamin C every 6 hours for 4 days, hydrocortisone 50 mg every 6 hours for 7 days, neurobion two ampoules every 12 hours for 4 days.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive a placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Arash Masoudpour
Street address
Sofeh street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
arash1360@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3791 3070
Email
Sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arash Masoudpour
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
ِDepartment of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
36692174
Email
arash1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Taghi Hashemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
st_hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, school of medicine, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 23728081
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to a government agency and cannot be shared.